Acalabrutinib vs Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+122 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.

Eligibility Criteria

This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) who have high-risk factors like certain genetic deletions or active disease requiring treatment. They must have had at least one prior CLL therapy, meet specific blood cell count criteria, and not be dependent on blood transfusions. People with a history of CNS leukemia, recent major surgery, or exposure to similar drugs are excluded.

Inclusion Criteria

Meet the following laboratory parameters: Absolute neutrophil count (ANC) ≥ 750 cells/μL or ≥ 500 cells/μL in participants with documented bone marrow involvement, and independent of growth factor support 7 days before assessment, Platelet count ≥ 30,000 cells/μL without transfusion support 7 days before assessment. Participants with transfusion-dependent thrombocytopenia are excluded, Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN), Total bilirubin ≤ 1.5 x ULN, Estimated creatinine clearance ≥ 30 mL/min

I have high-risk CLL with specific genetic changes or need treatment based on certain criteria.

I can care for myself and am up and about more than 50% of my waking hours.

+2 more

Exclusion Criteria

I need treatment with a strong medication that affects liver enzymes.

I have been diagnosed with CNS lymphoma or leukemia.

I have uncontrolled autoimmune blood disorders.

+12 more

Participant Groups

The study compares the effectiveness of two drugs in treating CLL: Acalabrutinib and Ibrutinib. It focuses on which drug better prevents the disease from getting worse in patients who've already been treated before.

2Treatment groups

Experimental Treatment

Active Control

Group I: AcalabrutinibExperimental Treatment1 Intervention

Participants will receive oral acalabrutinib 100 mg twice daily (BID) until disease progression (PD), or unacceptable toxicity, or other reasons for discontinuation, whichever occurs first.

Group II: IbrutinibActive Control1 Intervention

Participants will receive oral ibrutinib 420 mg once daily (QD) until PD, or unacceptable toxicity, or other reasons for discontinuation, whichever occurrs first.